The Food and Drug Administration (FDA) has submitted a proposed collection of information involving certifications to accompany drug, biological products and device applications or submissions to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act. Comments must be submitted by October 26, 2011.
According to the Federal Register notice, amendments to the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act require “that a certification accompany human drug, biological, and device product submissions made to FDA,” including expanded information about results of clinical trials. The agency proposes to extend the collection of information to meet statutory requirements. OMB certification control numbers and expiration dates for human drugs have already expired, but those for biological products expire December 31, 2011, and those for device products expire December 31, 2013. Those failing to submit required certification are subject to civil penalties.
FDA previously published a notice seeking public comment on its proposed collection of information and received several comments. This notice discusses the comments and reiterates the time burdens FDA estimated for the collection of information involving the certification requirement. See Federal Register, September 26, 2011.